Amarin Corp PLC News - AMRN

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Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

-- VASCEPA Approved by the National Medical Products Administration (NMPA) To Reduce the Risk of Cardiovascular...

Form 8-K - Current report

Amarin Board of Directors Announces CEO Transition

-- Board Appoints Aaron Berg as President & CEO -- -- Patrick Holt to Step Down as President & CEO to...

Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.

-- Greek Ministry of Health approved VAZKEPA® (icosapent ethyl) for national reimbursement to reduce...

Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference

DUBLIN, Ireland and BRIDGEWATER, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN...

Amarin Reports First Quarter 2024 Business Update and Financial Results

-- New VAZKEPA® Patent Issued by European Patent Office Extends Intellectual Property Protection in Europe...

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

DUBLIN, Ireland and BRIDGEWATER, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

Amarin Announces Results of Annual General Meeting of Shareholders

DUBLIN, Ireland and BRIDGEWATER, N.J., April 22, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024

DUBLIN, Ireland and BRIDGEWATER, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

DUBLIN, Ireland and BRIDGEWATER, N.J., April 08, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups Canada...

New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

-- Findings Presented on VASCEPA/VAZKEPA Utility in REDUCE-IT Patient Subgroups by Baseline High/Low Lp(a...

Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe

DUBLIN, Ireland and BRIDGEWATER, N.J., April 03, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc...

Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo

-- Subgroup Analyses from REDUCE-IT® and Mechanistic Data on Icosapent Ethyl(IPE)/Eicosapentaenoic Acid (EPA...

Form ARS - Annual Report to Security Holders

Whalatane 2 hours ago

Oh bother :--)
Required Studies:
The studies may include:
Preclinical Studies: In vitro and in vivo animal studies to evaluate the pharmacokinetic, pharmacodynamic, and toxicological profile of the drug with its new route of absorption.
Clinical Trials: Phase I, II, and III clinical trials will be necessary to determine the safety and efficacy in humans. These trials will compare the lymphatic absorption route with current standard methods.

Kiwi

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Whalatane 2 hours ago

JR. the fastest / easiest way is to work with NVS on the trial they are currently running for Inclisiran in Germany
Other then that ...read my response to N7
Good luck tomorrow
I think this is may be the trial
VICTORION-(NCT05030428)
Full Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease

Description: This Phase III trial investigates whether inclisiran, a small interfering RNA (siRNA) therapy targeting PCSK9 to lower LDL-cholesterol (LDL-C), reduces major adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke. Participants receive 300 mg inclisiran sodium (or placebo) subcutaneously on Day 1, Day 90, and every 6 months thereafter.

Status: Actively recruiting, with an estimated primary completion date of December 2027.

Relevance to Germany: This is a global trial with sites in multiple countries. Germany, a key player in European cardiovascular research, is highly likely to be involved, especially given its participation in prior inclisiran trials (e.g., ORION-11). Specific German sites aren’t always publicly detailed mid-trial, but Munich, Berlin, or Leipzig are plausible locations based on past patterns.

May not be the trial I was thinking off . They are running one exclusively in Germany ...20 mth on drug

Kiwi

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Whalatane 2 hours ago

Sure ...this is the easiest / fastest way ...but they may not qualify if as Capt says ..its bypass's the liver

The 505(b)(2) pathway is a type of New Drug Application (NDA) in the United States, defined under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. It’s a hybrid approval process overseen by the FDA that allows a drug sponsor to rely, at least in part, on existing data not developed by the applicant—such as data from a previously approved drug—while supplementing it with their own studies. This distinguishes it from a full 505(b)(1) NDA, which requires all original data, and from a 505(j) generic drug application, which relies entirely on bioequivalence to an existing drug.

The pathway is often used for drugs that are variations of already-approved products. Examples include new formulations (e.g., extended-release versions), new indications, new dosage forms, or combinations of previously approved drugs. It’s a cost- and time-efficient route because it avoids duplicating studies already conducted, like some preclinical or safety trials, but it still requires the applicant to provide evidence of safety and efficacy for the proposed changes.

A key feature is that the referenced drug (the "listed drug") must be an FDA-approved product, and the applicant can cite publicly available data, like published studies, or data from the listed drug’s NDA, though they may need a right of reference if the data isn’t public. The 505(b)(2) also triggers a review of potential patent or exclusivity issues tied to the listed drug, which can lead to delays if there’s a 30-month stay due to litigation or a period of market exclusivity (typically 3 to 7 years, depending on the change).
It’s a strategic option for companies looking to innovate without starting from scratch. Think of it like remixing a song—you use the original track but add your own spin, and you still need to prove it works.

Kiwi

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rosemountbomber 3 hours ago

On my Yahoo Finance for Amarin it shows an estimate of -.03 for tomorrow. I think earnings will not be that important. Cash drawdown, and what they say will be critical. Unless that loss of 3 cents shows up as a loss in the double digits. Good luck to all of us.

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rosemountbomber 3 hours ago

Agree that the new formulation has to be the carrot they dangle in front of BP. Will it be enough to entice them, who knows.

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JRoon71 3 hours ago

Kiwi, I do not know enough about drug trial requirements to know if this is the case. But even if it is, it does not mean that a BP is not willing to buy Amarin and assume the responsibility of running the trials themselves, post-acquisition. If there is a strong enough case for the new formulation, then a BP may be willing to pay good money for it.

The fact is, if Amarin was not planning to leverage the R&D they are doing on the new formulation, they wouldn't be wasting the money and resources on its development.

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couldbebetter 4 hours ago

That is some interesting research. I really
hope AMRN is keeping this secret for competitive
reasons...However, I hope if that is the case they
would disclose whatever they can as to what their
game plan is and how well it is working.

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rosemountbomber 4 hours ago

Perkins Cole who represented Amarin and won the Appeal against Hikma, is apparently suing the Administration. Not sure if this affects their representation of Amarin.

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rosemountbomber 4 hours ago

Well that didn't work too well:

https://www.google.com/search?q=does+the+fda+require+new+studies+for+drugs+using+lymphatic+system+for+absorption+rather+than+portal+vein&ie=UTF-8&oe=UTF-8&hl=en-us&client=safari

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rosemountbomber 4 hours ago

I am guessing the new formulation would be the additional kicker to coax a BP into a deal. Don't know how many hoops or how long it would be that tge FDA would require but it is doubtful a current standalone Amarin could do it. Here is an AI take on this:

"AI Overview
+1
Yes, the FDA generally requires new studies if a drug's absorption route relies on the lymphatic system, rather than the conventional portal vein, because the lymphatic system offers a unique pathway that can bypass the liver's first-pass metabolism. Here's a more detailed explanation:Lymphatic System as an Alternative:The lymphatic system provides an alternative pathway for drug transport, enabling a bypass of the liver's first-pass metabolism. Significance of First-Pass Metabolism:Drugs absorbed into the portal vein (the conventional route) undergo first-pass metabolism in the liver, which can significantly reduce their bioavailability (the amount of drug that reaches systemic circulation). Lymphatic Absorption Benefits:Drug transport via the intestinal lymph circumvents this first-pass metabolism, potentially enhancing oral bioavailability, especially for drugs that are highly metabolized in the liver. FDA Requirements:While the FDA doesn't have specific requirements, researchers must conduct adequate studies to demonstrate the safety and efficacy of drugs absorbed via the lymphatic route, and they must also address any concerns related to the unique characteristics of lymphatic absorption. Examples:Some examples of drugs that have shown improved bioavailability when delivered via the lymphatic system include methotrexate, paclitaxel, and cyclosporine. Focus of Research:More research and innovative technologies are being explored to exploit the lymphatic system for targeted drug delivery. "

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Number sleven 5 hours ago

Kiwi, Please post the FDA guidance that supports your opinion.
Sleven,

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couldbebetter 5 hours ago

CPT, Would be great to see some confirmation of this
from AMRN, along with the game plan for the development
of this new EPA formulation. I would also like to see what
Dr. Bhatt has to say about this new formulation. Your excellent
graphic on this would make it possible for the concept to be
explained to a BP in just a few minutes. (My fantasy would
be for Alex Denner & Dr. Bhatt use the graphic to explain this
to NVS.) As always, my POV is that the sooner a BP gets behind
this, either through a JV, BO, or partnership arrangement, the better
the legal, financial, and political protection that could accrue to this.

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north40000 5 hours ago

Thanks for that word/image discussion, Capt.--perhaps the statin could still be eliminated for statin-intolerant individuals.

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Number sleven 5 hours ago

North, If you have the contacts, you should reach out.
Sleven,

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north40000 5 hours ago

I currently don't know if the CEOs of Dr. Reddy or Hikma were in the room to hear this, but CNBC-TV today reported that the FTC Chairman just promised those CEOs that were in a meeting with him that the FTC will take their companies to Court if it finds any conduct events or merger activity that hurts/harms the American population.

Sounds to me that the FTC is very ready to investigate the fraudulent, culpable, inequitable conduct/activity of those 2 miscreants in their post-trial court brief in a Nevada District Court a few years ago. What the FTC/DOJ/FBI now need are the facts and law related in our Amarin stockholder/EPA Drug Initiative II Petition for Writ of Certiorari, on which facts/law no court or federal agency has expressed a rationale opinion. The cardiovascular and monetary health of the United States has been compromised/harmed by their post-trial actions, deliberately imposed on the Courts.

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Whalatane 5 hours ago

Capt. you know that to get the R-IT indication for this new formulation that bypass's the liver ??...AMRN would need to run a large double blinded Outcome trial for at least several years . But whats another 5 plus years and mucho $ , between friends
Kiwi

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ramfan60 6 hours ago

That would be phenomenal .......

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CaptBeer 6 hours ago

This is how we get the US IPE market back!

Here’s a quick illustration that distinguishes the differences in the uptake of EPA between VASCEPA®’s current formulation and the forthcoming LR-EtEPA formulation. The current formulation (Plain-EPA) is delivered through the Portal Vein Delivery System. In this system the first pass is through the liver which absorbs a significant amount of the EPA thus diluting the uptake at the target organs.

On the other hand, the Lymphatic Delivery System bypasses the liver and delivers directly to the target organs. The process is described in the LR-EtEPA patent application (WO2023146984). This new formulation can deliver from 170-296% more EPA to affected organs than the Portal Vein System. This could increase drug compliance, reduce the number of daily doses, cut Rx prices 50-75% and very importantly, incorporate easily with a Statin + VASCEPA® one a day combo pill!

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alwayswatching1 6 hours ago

Honestly I really like the setup here. $10 is my long term PT. I think Denner gets it done by the EOY. Most will exit along the way up but those that hang tough will be rewarded once again IMO.

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Number sleven 7 hours ago

https://www.courtlistener.com/docket/59859757/dr-reddys-laboratories-inc-v-amarin-pharma-inc/?page=2
Sleven,

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seve333 7 hours ago

Good luck to Jron the short tomorrow. My guess is its going to be same old same old its undervalued blah blah blah. Hopefully I am wrong if now Jron will probably make money on his short tomorrow.

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mrmainstreet 8 hours ago

Elect clowns you get a circus

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Monk4444 9 hours ago

"I am just waiting for the MDCO blueprint to play out"
Larrybirdlegend
Me too

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seve333 10 hours ago

If Jron is to be believed Denner has had master plan all along and is just waiting to unleash it.

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JRoon71 10 hours ago

I actually think they could do both of these when the new formulation is ready. I think it is how they take back the U.S. market.

ramfan60 10 hours ago

Selling to a BP for $10/sh would be new...... let's do that instead

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ziploc_1 11 hours ago

Amarin needs to do something new.....An AG or a start to develop LR Et EPA comes to mind.

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rosemountbomber 11 hours ago

In less than 20 hours we will find out if it will be mums the word or whether there is some sort of as of yet undisclosed plan. Setting my alarm since I am now in a left coast time zone. No matter what, unfortunately the market is in a state of turmoil. What's new.

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lizzy241 12 hours ago

North, these 2 patents are tied to the Amarin and Mochida collaboration for FDC.

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lizzy241 12 hours ago

North, I've tried to copy and paste but the PDF files are protected from being copied. Below is an excerpt from one of the files. From EU patent files.

EP4338805 – EPA for use in reducing the risk of NON-FATAL MYOCARDIAL INFARCTION in a subject on statin therapy
Status: 15.01.2025 Grant of patent is intended

EP4342546 – EPA for use in treating the risk of NON-FATAL STROKE in a subject on statin therapy
Status: 15.01.2025 Grant of patent is intended

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ralphey 14 hours ago

Give the man his due , He is an expert on predicting the past

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ralphey 14 hours ago

Great INformation ! Stock now in the 40's this is yet again another wonderful buying opportunity BUY BUY BUY . The charts show a double kangaroo houdin inversion coming I tell you what it means after it happens

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seve333 14 hours ago

Management never says a work. Nobody has any idea what is going on so it does not matter if they have 300 million in cash.

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ramfan60 15 hours ago

Well Rosem...... I figured over and above helping to find waste, fraud, and abuse in the government, there would be benefits to TESLA when it comes to getting regulatory approval for Full Self Driving and Optimus robots..... we'll see. In the mean time, I sure hope we start getting upside surprises tomorrow and get this AMRN investment out of the toilet.

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lizzy241 15 hours ago

North is there a problem opening the link? on left side, it shows a link for "all documents"
Below is link the grant of one patent.
https://register.epo.org/application?documentId=M5VLYMREQQFGE5M&number=EP24152359&lng=en&npl=false

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north40000 15 hours ago

I agree, sleven. New patents, new generics with unknown compositions in capsules, and new patent infringement suits filed against new and old generics where appropriate. Nothing absurd about that--even generics are aware in Delaware and New Jersey in current litigation.

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north40000 15 hours ago

Save everyone some time, lizzy, and print text of application or patent claims shown in respective claims. I'll return later tonight to view those claims.

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JRoon71 16 hours ago

fear of the unknown may have driven some sellers

BBI, this is pretty much what Denner has done since he took over - or at least for the past 18 months. Stop virtually all communication and leave everyone wondering. It has all been planned.

He has raised HUGE cash in the past 24 months ($600M+). His filings currently show only $290M in total investments. That's down $700M from the peak just a few years ago. Something big is going down.

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JRoon71 16 hours ago

Sleven, not sure I follow. If one or some of the generics stop selling IPE, then the others will naturally pick up that slack. PBM's will get their supply somewhere. I don't see what's absurd about that.

As to the tariffs, we don't quite know how that's going to impact each generic yet.

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rosemountbomber 17 hours ago

Ram, congrats on your good timing. You got the calvalry coming in last night:

<a href="

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hayward 1 day ago

FlyFishingStocks

Since Tesla also went down close to 25% Inc after hours are they going to 0 ? Many days after you said we would follow the market down but did not where were you then ? Seems you post only when the market fits your predictions IMO

Michael

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Jasbg 1 day ago

BBI, With you all the way here'. Where we are (in value) - we just have to trust/believe that Sarissa/Denner have a plan.

This is 'What They Do' - how Denner made his Business - Making turnarounds in the Market' - against experts expectations'.
------------------------------------------------

Truth is that Amarin and Vascepa/Vazkepa is even further out than Trump' - aiming to concur this Planet - so no reason to Give up Hope - Yet 🙂

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FlyFishingStocks 1 day ago

Volume interaction with overhead resistance has governed price direction.

Last week I shared this chart showing double top patterns where feeble up volume (B) led to a sharp sell off on heavy volume.

The volume reliably forecasted today's outcome

Todays chart:

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Birdbrain Ideas 1 day ago

I do recall the report three years ago when Amarin lost $50 million or $70 million in a quarter and it seemed that the share price was falling nonstop for two months before earnings were announced so it was clear that word had spread. This quarter, we've seen the opposite, where the stock has risen more days than not since the start of the year and volume has remained muted. I think if there was particularly bad news coming out, the company might have preannounced. Same if there was good news. Still, I guess it's possible that we lost $20 million in the Fourth Quarter. Hope not, but it's possible. And that might explain why there has been no rush to start a share buyback. Or maybe they're preparing to announce a way to get the share price over $1 that won't make investors happy. Besides the market's collapse today, fear of the unknown may have driven some sellers.

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Number sleven 1 day ago

JRroon , I wasn't asking a question your response was absurd.
Sleven,

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lizzy241 1 day ago

proliberty, could be margin calls not for AMRN but other stocks. KIM For every seller there's a buyer.

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FlyFishingStocks 1 day ago

As TA forecasted, the .43 cent target was reached on the downside based on this chart I posted 1 week ago

The stock printed a new low today of .40. Wow... that is a -25% plunge intra-day.

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ProLiberty 1 day ago

Agreed. And in a typical company dominated by management and a captured BOD, you might well see enrichment of insiders at expense of shareholders / a full burn of any cash. In this case, Sarissa is in full control and should be able to force further cost cuts and a sale if the best option to avoid massive cash burn.

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rosemountbomber 1 day ago

No question that it seems ridiculous. However, market is forward looking. It must think that revenue from the EU will not come fast enough to make up for losses here. Only thing I can think of that the market thinks that cash will evaporate in the future. Important to have an earnings report and CC that instills confidence that that won't happen.

I should add, that the market is sometimes pretty stupid. Huge valuations for companies that aren't making any money and many examples of stocks bashed to hell and lo and behold they resurrect.

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Amarin Corp PLC (AMRN)

Real-time discussions and trading ideas: Trade with confidence with our powerful platform.

AMRN News

Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

Form 8-K - Current report

Amarin Board of Directors Announces CEO Transition

Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.

Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference

Amarin Reports First Quarter 2024 Business Update and Financial Results

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

Amarin Announces Results of Annual General Meeting of Shareholders

Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe

Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo

Form ARS - Annual Report to Security Holders

AMRN Discussion

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Amarin Corp PLC (AMRN)

Real-time discussions and trading ideas: Trade with confidence with our powerful platform.

AMRN News

Amarin Partner EddingPharm Receives Regulatory Approval for VASCEPA® (Icosapent Ethyl) in Mainland China for Cardiovascular Risk Reduction (CVRR)

Form 8-K - Current report

Amarin Board of Directors Announces CEO Transition

Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A.

Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference

Amarin Reports First Quarter 2024 Business Update and Financial Results

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

Amarin Announces Results of Annual General Meeting of Shareholders

Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024

Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24

New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups

Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe

Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo

Form ARS - Annual Report to Security Holders

AMRN Discussion

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